FDA 510(k) Application Details - K102951

Device Classification Name	More FDA Info for this Device
510(K) Number	K102951
Device Name	EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)
Applicant	EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 US Other 510(k) Applications for this Company
Contact	GRAHAM L CUTHBERT Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/2010
Decision Date	11/04/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review